Denver, CO: The daily consumption of hemp-derived CBD products for two months or more is not associated with adverse impacts on the liver, according to preliminary results shared with the US Food and Drug Administration. Regulators at the FDA had requested a safety analysis regarding subjects’ use of hemp-derived CBD products in its report to Congress last year.
Investigators involved with the study reported that the ingestion of CBD products was not associated with any risk of liver disease in a cohort of 839 subjects.
“Our primary endpoint in this study is to observe potential liver effects in adults ingesting oral forms of hemp-derived CBD for a minimum of 60 days. What we observed to date is no clinical evidence of liver disease in any participants,” co-investigator Jeff Lombardo stated in a press release.
A second investigator added: “We are encouraged by these findings and hopeful this study provides FDA with sufficient science-based data to determine and take action on a safe regulatory path forward. We will continue to analyze these real-world data and are adding a second cohort to this study to increase statistical certainty for liver safety and secondary measures across diverse populations and consumers with various medical conditions.”
Last year, the FDA informed Congress that it “is actively evaluating what and how much data would be sufficient to support a conclusion that CBD can be safely allowed in dietary supplements under certain conditions.”
For more information, see NORML’s fact sheet, “FAQs About Cannabidiol (CBD).”